Removal of opioid/acetaminophen combination prescription pain medications: assessing the evidence for hepatotoxicity and consequences of removal of these medications.

Opioid/acetaminophen combination products are widely prescribed for the management of moderate to moderately severe pain. Acetaminophen, when improperly used, can lead to liver damage and even acute liver failure. In June 2009, an FDA advisory committee recommended elimination of prescription acetaminophen combination products because of the risk of hepatotoxicity associated with use of these medications. The FDA advisory committee reviewed numerous observational studies and adverse event reporting data. The aims of this article are to: 1) provide a summary and epidemiologic critique of the studies and evidence the FDA advisory committee reviewed; 2) examine the potential consequences, such as poorly managed pain or a shift to treatment with other medications with greater potential toxicity and/or restricted availability, if the FDA follows the advisory committee vote; and 3) outline alternate strategies the FDA should consider for reducing hepatotoxicity associated with opioid/acetaminophen combination products.

Opioid analgesics for pain control: wisconsin physicians' knowledge, beliefs, attitudes, and prescribing practices.

OBJECTIVE: Opioid analgesics are the drugs of choice for the treatment of moderate to severe acute and cancer pain. Although their role in the management of chronic pain not related to cancer is controversial, there is increasing evidence for their benefit in certain patient populations. DESIGN: A 32-item survey to assess Wisconsin physicians' knowledge, beliefs, and attitudes toward opioid analgesic use was mailed to 600 randomly selected licensed physicians, resulting in a 36% response rate. RESULTS: Half of the respondents considered diversion a moderate or severe problem in Wisconsin. A majority considered addiction to be a combination of physiological and behavioral characteristics, rather than defining it solely as a behavioral syndrome. Most physicians felt it lawful and acceptable medical practice to prescribe opioids for chronic cancer pain, but only half held this view if the pain was not related to cancer. Fewer physicians considered such prescribing as lawful and generally accepted medical practice if the patient had a history of substance abuse. About two-thirds of physicians were not concerned about being investigated for their opioid prescribing practices, but some admitted that fear of investigation led them to lower the dose prescribed, limit the number of refills, or prescribe a Schedule III or IV rather than a Schedule II opioid. CONCLUSION: Wisconsin physicians who responded to this survey held many misconceptions about the prescribing of opioids. Such views, coupled with a lack of knowledge about laws and regulations governing the prescribing of controlled substances, may result in inadequate prescribing of opioids with resultant inadequate management of pain.

The Discomfort Behavior Scale: a measure of discomfort in the cognitively impaired based on the Minimum Data Set 2.0.

Because persons with cognitive impairment often cannot self-report pain, it is imperative to develop instruments that use observable indicators. The purpose of this study was to develop and test the psychometric properties of the Discomfort Behavior Scale (DBS), which is comprised of 17 items from the Minimum Data Set (MDS). MDS data from 29,120 cognitively impaired nursing home residents were used for psychometric testing. Factor analyses of the DBS indicated that it reflects a single discomfort dimension. The items are tau equivalent, allowing unity weighting and simple summation to create scale scores, and the internal consistency was good. The DBS has potential to be useful in studies of efforts to improve pain management in cognitively impaired residents of nursing homes.

The WPI's review of Wisconsin's managed care climate for pain management: opportunities for improvement.

BACKGROUND: Reimbursement obstacles, such as inadequate insurance coverage, have been identified as barriers to adequate pain management. The purpose of this study was to determine Wisconsin insurers' and managed care organizations' (MCOs) policies and practices regarding pain treatment and MCO medical directors' perceptions of barriers to providing effective pain management for their enrollees. METHODS: A descriptive qualitative design was used with semi-structured interviews of 6 administrative executives of commercial health management organizations' products from the major insurers in Wisconsin. RESULTS: None of the companies interviewed had systematically tracked data or had processes in place to allow them to track, analyze or trend data specific to pain management. Chronic noncancer pain is recognized more frequently as an insurance coverage issue because of high drug costs. Pharmacologic and interventional therapies are routinely covered compared with nonpharmacologic therapies with some prior authorizations, especially for newer medications. A uniformly identified barrier was lack of a comprehensive, interdisciplinary, integrated approach to pain management and inadequate data on the cost effectiveness of various approaches. CONCLUSIONS: Opportunities exist to educate and improve communication between health care professionals, purchasers of health care (employers), primary care providers and pain specialists. The economics of pain management needs to be made more "visible" through the development of coding and tracking mechanisms.

Institutionalizing effective pain management practices: practice change programs to improve the quality of pain management in small health care organizations.

The Resource Center of the American Alliance of Cancer Pain Initiatives provided templates, faculty, and ongoing consultation to assist seven state pain initiatives to implement programs to improve pain management practices. A total of 113 health care organizations participated. Each organization committed to support a team of two to three staff through a 10-month pain quality improvement process, which included a site visit, two educational conferences, pre- and postprogram analyses of the organizational structures in place to support pain assessment and management, quality improvement work plan development, and patient survey data collection. Postprogram results showed statistically significant increases in the presence of structural elements that are critical to effective pain management, as well as statistically significant, though modest, decreases in the percentage of patients who reported pain of any severity, and specifically moderate to severe pain, in the previous 24 hours. The largest changes occurred in long-term care facilities. Nevertheless, the percentage of patients in moderate to severe pain remained unacceptably high.

American pain society recommendations for improving the quality of acute and cancer pain management: American Pain Society Quality of Care Task Force.

BACKGROUND: The American Pain Society (APS) set out to revise and expand its 1995 Quality Improvement Guidelines for the Treatment of Acute Pain and Cancer Pain and to facilitate improvements in the quality of pain management in all care settings. METHODS: Eleven multidisciplinary members of the APS with expertise in quality improvement or measurement participated in the update. Five experts from organizations that focus on health care quality reviewed the final recommendations. MEDLINE and Cumulative Index to Nursing and Allied Health Literature databases were searched (1994-2004) to identify articles on pain quality measurement and quality improvement published after the development of the 1995 guidelines. The APS task force revised and expanded recommendations on the basis of the systematic review of published studies. The more than 3000 members of the APS were invited to provide input, and the 5 experts provided additional comments. The task force synthesized reviewers' comments into the final set of recommendations. RESULTS: The recommendations specify that all care settings formulate structured, multilevel systems approaches (sensitive to the type of pain, population served, and setting of care) that ensure prompt recognition and treatment of pain, involvement of patients and families in the pain management plan, improved treatment patterns, regular reassessment and adjustment of the pain management plan as needed, and measurement of processes and outcomes of pain management. CONCLUSION: Efforts to improve the quality of pain management must move beyond assessment and communication of pain to implementation and evaluation of improvements in pain treatment that are timely, safe, evidence based, and multimodal.

The use of 'as-needed' range orders for opioid analgesics in the management of acute pain: a consensus statement of the American Society for Pain Management Nursing and the American Pain Society.

The use of "as-needed" or "PRN" range orders for opioid analgesics in the management of acute pain is a common clinical practice. This approach provides flexibility in dosing to meet individual patients' unique analgesic requirements. Range orders enable necessary and safe dose adjustments based on an individual's response to treatment. This paper presents the consensus statement of the American Society for Pain Management Nursing and the American Pain Society on the use of "as-needed" range orders for opioid analgesics in the management of acute pain.

Myths about controlling pain.

Myths and misinformation about pain and its management often lead to poor therapy for patients in pain. Nine common myths about pain and its management are described and refuted.

The use of "as-needed" range orders for opioid analgesics in the management of acute pain: a consensus statement of the American Society for Pain Management Nursing and the American Pain Society.

The use of "as needed" or "PRN" range orders for opioid analgesics in the management of acute pain is a common clinical practice. This approach provides flexibility in dosing to meet individual patients' unique analgesic requirements. Range orders enable necessary and safe dose adjustments based on an individual's response to treatment. The purpose of this paper is to present the consensus statement of the American Society for Pain Management Nursing and the American Pain Society on the use of "as-needed" range orders for opioid analgesics in the management of acute pain. The implementation of this statement should promote quality pain management through safe medication practices and the appropriate use of range orders for opioid analgesics in acute pain management.

A reassessment of trends in the medical use and abuse of opioid analgesics and implications for diversion control: 1997-2002.

This study updates a previous analysis of trends in medical use and abuse of opioid analgesics, and provides data from 1997 through 2002. Two research questions were evaluated: 1) What are the trends in the medical use and abuse of frequently prescribed opioid analgesics used to treat severe pain, including fentanyl, hydromorphone, meperidine, morphine, and oxycodone? 2) What is the abuse trend for opioid analgesics as a class compared to trends in the abuse of other drug classes? Results demonstrated marked increases in medical use and abuse of four of the five studied opioid analgesics. In 2002, opioid analgesics accounted for 9.85% of all drug abuse, up from 5.75% in 1997. Increase in medical use of opioids is a general indicator of progress in providing pain relief. Increases in abuse of opioids is a growing public health problem and should be addressed by identifying the causes and sources of diversion, without interfering with legitimate medical practice and patient care.

Pain: impediments and suggestions for solutions.

Pain is a common and devastating symptom of cancer that can be effectively controlled with currently available pharmacological and non-pharmacological therapies. Unfortunately, there continue to be reports that half of patients with cancer have inadequate relief of their pain with devastating effects on their quality of life and functional status. Systematic efforts to understand and eliminate the barriers to effective pain control are essential if we are to make pain assessment and management an integral part of cancer care. Documented impediments are related to health care professionals; patients, families, and the public; and the health care, reimbursement, and drug regulatory systems. A research agenda that focuses on closing the gap between current knowledge and practice is essential to assuring that people with cancer are no longer subjected to the agony of unrelieved pain.

Institutionalizing pain management: the Post-Operative Pain Management Quality Improvement Project.

Clinical practice and quality improvement (QI) guidelines for acute postoperative pain management have been developed to address the well-documented problem of undertreatment of postoperative pain. The Post-Operative Pain Management Quality Improvement Project (the POP Project) was initiated to determine whether an intervention designed to support hospitals in the development of QI efforts would lead to improvements in structures, processes, and outcomes consistent with recommended guidelines. A nationwide sample of 233 hospitals joined the project. The intervention consisted of written resource materials accompanied by support services that included an e-mail list server, a resource Web page, and assistance from POP Project staff via telephone. Data regarding critical structures, processes (practice patterns), and patient outcomes were collected at baseline before the intervention began and at follow-up 12 to 18 months later. Results showed a statistically significant increase from baseline (45%) to follow-up (72%) in the presence of structural elements that are critical to improving pain management. There were statistically significant improvements in practices including documented use of pain rating scales, decreased use of intramuscular opioids, and increased use of nonpharmacologic strategies. Patient survey data showed no change in pain outcomes. Evaluation data showed that 70% of hospitals were very or extremely satisfied with their participation in the POP Project and 90% of them planned to continue efforts to improve pain management after the POP Project ended. Further research is needed to determine how to translate the excellent results obtained for structure and process into meaningful outcomes for patients.

Success of the state pain initiatives: moving pain management forward.

PURPOSE: The purpose of this article is to describe the history of the State Cancer Pain Initiative (CPI) movement and current initiative activities that are directed at improving the management of cancer pain. OVERVIEW: The undertreatment of pain is a major public health problem in the United States. State CPIs strive to remove the barriers to effective cancer pain management through the provision of innovative professional, patient, and public educational programs, through institutional change projects, and through public advocacy. Collaboration with organizations that share common goals is important in sustaining and maximizing the impact of the movement. CLINICAL IMPLICATIONS: Professionals, patients, and families benefit from the work of the State Initiatives. By enhancing the knowledge and skills of clinicians, supporting institutional change, and teaching patients and families the importance of effective pain control, the Initiatives help to improve the quality of life for all cancer survivors. Models of intervention that respond to local needs are discussed, and legislative and advocacy efforts that affect care also are noted.

Pain management and prescription monitoring.

Preventing diversion and abuse of prescription controlled substances while ensuring their availability for legitimate medical use is an important public health goal in the United States. In one approach to preventing and identifying drug diversion, 17 states have implemented prescription monitoring programs (PMPs) to monitor the prescribing of certain controlled substances. While PMPs are not intended to interfere with legitimate prescribing, some in the pain management community feel that they negatively affect prescribing for pain management. This article describes a collaborative project initiated by the Pain & Policy Studies Group that brought together regulatory and pain management representatives twice in 1998 to share perspectives and reconcile differing views on the effects of PMPs. The ultimate goals of this project are to provide accurate information to healthcare clinicians about PMPs, better define the balance between preventing drug diversion and providing pain management, and promote continued dialog and cooperation among the groups.

Pain management, controlled substances, and state medical board policy: a decade of change.

Physicians' concerns about regulatory scrutiny and the possibility of unwarranted investigation by regulatory agencies negatively affect their prescribing of opioid analgesics to treat pain. Indeed, some state medical boards have rejected prescribing practices that are considered acceptable by today's standards. This article describes a ten-year program of research, education, and policy development implemented by the Pain & Policy Studies Group aimed at updating and clarifying state medical board policies on the use of opioid analgesics to treat pain, including cancer and chronic noncancer pain. Following surveys of medical board members and educational workshops, state medical board policies began an initial period of change, drawing on guidelines from other states, particularly in California. The next phase of policy development was marked by the introduction of Model Guidelines by the Federation of State Medical Boards of the U.S. The Model Guidelines address professional standards for the appropriate prescribing of opioid analgesics for pain management, as well as physicians' fears of regulatory scrutiny. Although most state medical boards have adopted regulations, guidelines, or policy statements relating to controlled substances and pain management, to date ten boards have adopted the Model Guidelines, while ten more have adopted the Model Guidelines in part. Further actions are recommended so that state medical boards can address inadequate pain management and physician concerns about regulatory scrutiny.